Hier “rcpe ppt header Large 01.emf” platzieren Drug Research and Development for Adults Across the Older Age Span The Era of COVID-19 and Beyond The National Academies of Sciences, Engineering and Medicine Sven Stegemann Professor for Patient Centric Drug Development and Manufacturing Graz University of Technology K1 Competence Center - Initiated by the Federal Ministry of Transport, Innovation and Technology (BMVIT) and the Federal Ministry of Science, Research and Economy (BMWFW). Funded by the Austrian Research Promotion Agency (FFG), Land Steiermark and the Styrian Business Promotion Agency (SFG). The context of drug development and healthcare technology Covid-19 Quality, Safety and efficacy Special patient populations Policies and Regulations Development Clinical trials Scientificand clinical (incl PFDD) (incl pediatrics & geriatrics) Healthcareprovision evidence Discovery Dev. & clinical trail Patients & Fast track, break through & orphan Technology New modalities Innovation (CAR-T cells) (wearable diagnostics, Digital health programs telemed) Use & generate scientific and clinical evidence directly to patients e.g. Remdesivir, SARS-CoV2 vaccine, digital healthcare, new clinical trials design,... Agenda – August 6, 2020 – 12.00 pm – 1.30 pm Opening remarks by panel moderator, European perspective SVEN STEGEMANN Lessons learned from COVID-19 (12.00 – 1.00 pm) U.S. regulatory changes Digitization of medicine HARPREET SINGH ERIC TOPOL Division Director (Acting) Founder and Director U.S. Food and Drug Administration, Division of Oncology 2 Scripps Research Translational Institute Infectious disease perspective Patient perspective JOHN POWERS BEVERLY CANIN Senior Medical Scientist Patient Advocate Leidos Biomedical Research Cancer and Aging Research Group Telehealth / Physician perspective ERIKA RAMSDALE Panel discussion (1.00 – 1.30 pm) Assistant Professor University of Rochester Medical Center.